Drugmaker Cipla, through subsidiary Invagen Pharmaceuticals, has entered into a partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply of QL2107, a biosimilar to Keytruda (pembrolizumab) in the U.S.

Qilu will be responsible for development, regulatory registration and supply of the product while Cipla USA Inc. will be responsible for the commercialisation of the asset by leveraging its strong commercial presence in the defined territory, the company said on Thursday (September 3).

The partnership reflects Cipla’s confidence in the long-term potential of biosimilars and supports its strategy to build a strong oncology-focused portfolio, said Achin Gupta, MD and and Global CEO of Cipla.

“With our established commercial capabilities, we are well-positioned to successfully launch QL2107, subject to regulatory approval, and help ensure it reaches patients in need while lowering the cost of treatment,” Cipla North America CEO Marc Falkin said.

Qilu Pharmaceutical General Manager Hanchang Zhang said “by combining our R&D and manufacturing strengths with Cipla’s U.S. commercial expertise, we aim to bring a high-quality, affordable pembrolizumab biosimilar to U.S. patients.”

Cipla has received approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in three strengths — 100/50 mcg, 250/50 mcg, and 500/50 mcg .

This approval represents Cipla’s first dry powder inhaler (DPI) approval from its U.S.-based manufacturing network. The product is expected to be launched in the second quarter (Q2) of FY27 in the U.S., the company said on Monday.

The product is a therapeutically equivalent version of Advair Diskus, a widely prescribed combination therapy indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Citing IQVIA numbers, Cipla said the U.S. market for fluticasone propionate and salmeterol inhalation powder is approximately $908 million.

“This approval marks our first dry powder inhaler from our New York facility and reflects our targeted investments in building differentiated inhalation manufacturing capabilities in the U.S,” CEO-Cipla North America Marc Falkin said.

MD and Global CEO Achin Gupta said the approval reinforces Cipla’s commitment to expanding access to complex therapies in the U.S. and highlights its strength in developing and scaling sophisticated inhalation products through integrated capabilities.”